Trikafta and Tinnitus - a phase IV clinical study of FDA data

Summary:

Tinnitus is reported as a side effect among people who take Trikafta (elexacaftor, ivacaftor, tezacaftor; ivacaftor), especially for people who are female, 10-19 old, have been taking the drug for 1 - 6 months also take Pulmozyme, and have Cystic fibrosis.

The phase IV clinical study analyzes which people have Tinnitus when taking Trikafta. It is created by eHealthMe based on reports of 11,845 people who have side effects when taking Trikafta from the FDA, and is updated regularly.

What is Trikafta?

Trikafta has active ingredients of elexacaftor, ivacaftor, tezacaftor; ivacaftor. eHealthMe is studying from 11,852 Trikafta users. Check the latest studies of Trikafta.

What is Tinnitus?

Tinnitus (a ringing in the ears) is found to be associated with 1,668 drugs and 3,065 conditions by eHealthMe. Check the latest studies of Tinnitus.

eHealthMe: drug outcomes in the real world

eHealthMe runs one of the largest post-marketing drug safety studies in the world. We study millions of patients and 5,000 more each day. Our data-driven phase IV clinical trials have been referenced on 800+ peer-reviewed medical publications including The Lancet, Mayo Clinic Proceedings, and Nature. Tools to study our phase IV findings are available to the public, anonymous and free >>>.

On Sep, 02, 2026

11,845 people reported to have side effects when taking Trikafta.
Among them, 38 people (0.32%) have Tinnitus.

Among these 38 people:

How long have people been on Trikafta when they have Tinnitus? *

What is the gender of people who have Tinnitus when taking Trikafta? *

female: 72.97 %
male: 27.03 %

What is the age of people who have Tinnitus when taking Trikafta? *

What are other drugs people take besides Trikafta? *

What are other side effects people have besides Tinnitus? *

Headache (pain in head): 13 people, 34.21%
Weight Increased: 10 people, 26.32%
Dizziness: 10 people, 26.32%
Diarrhea: 9 people, 23.68%
Neuropathy Peripheral (surface nerve damage): 8 people, 21.05%
Abdominal Distension: 6 people, 15.79%
Oedema Peripheral (superficial swelling): 5 people, 13.16%
Hot Flush (sudden feelings of heat): 5 people, 13.16%
Hair Loss: 5 people, 13.16%
Body Temperature Increased: 5 people, 13.16%

What are the existing conditions these people have? *

Cystic Fibrosis (disease of the secretary glands): 38 people, 100.00%
Nosebleed (bleeding from nose): 2 people, 5.26%
Mycobacterium Avium Complex Infection: 2 people, 5.26%
Mycobacterial Infection: 1 person, 2.63%
Atypical Mycobacterium Test Positive: 1 person, 2.63%
Abdominal Pain Upper: 1 person, 2.63%

* Approximation only. Some reports may have incomplete information.

Do you take Trikafta and have Tinnitus?

- Check whether Tinnitus is associated with a drug or a condition
- Predict drug outcomes for up to one year with AI
- Get an AI agent to monitor your drugs continuously

Related studies:

Effectiveness of, long term effects of, and alternative drugs to Trikafta:

Trikafta (11,852 reports)

Tinnitus treatments and more:

Tinnitus (58,554 reports)

How severe was Tinnitus and when was it recovered:

Tinnitus in Trikafta

Expand to all the drugs that have ingredients of elexacaftor, ivacaftor, tezacaftor; ivacaftor:

Tinnitus and drugs with ingredients of elexacaftor, ivacaftor, tezacaftor; ivacaftor

Sub-studies by gender and age:

Female: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Male: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Browse all side effects of Trikafta:

a b c d e f g h i j k l m n o p q r s t u v w x y z

Browse all the drugs that are associated with Tinnitus:

Tinnitus (1,668 drugs)

Browse all the conditions that are associated with Tinnitus:

Tinnitus (3,065 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on elexacaftor, ivacaftor, tezacaftor; ivacaftor (the active ingredients of Trikafta) and Trikafta (the brand name). Other drugs that have the same active ingredients (e.g. generic drugs) are not considered. Dosage of drugs is not considered in the study.

How to use the study?

DO NOT STOP MEDICATIONS without first consulting your doctor. If there are any serious or long term adverse effects discovered in the study, discuss the study with your doctor to ensure that proper medication management will be in place if applicable.

Who is eHealthMe?

With medical big data and proven AI/ML algorithms, eHealthMe provides a platform for everyone to run phase IV clinical trials. We study millions of patients and 5,000 more each day. Results of our real-world drug study have been referenced on 800+ peer-reviewed medical publications, including The Lancet, Mayo Clinic Proceedings, and Nature. Our analysis results are available to researchers, health care professionals, patients (testimonials), and software developers (open API).

WARNING, DISCLAIMER, USE FOR PUBLICATION

WARNING: Please DO NOT STOP MEDICATIONS without first consulting a physician since doing so could be hazardous to your health.

DISCLAIMER: All material available on eHealthMe.com is for informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment provided by a qualified healthcare provider. All information is observation-only. Our phase IV clinical studies alone cannot establish cause-effect relationship. Different individuals may respond to medication in different ways. Every effort has been made to ensure that all information is accurate, up-to-date, and complete, but no guarantee is made to that effect. The use of the eHealthMe site and its content is at your own risk.

If you use this eHealthMe study on publication, please acknowledge it with a citation: study title, URL, accessed date.